impaired thyroid function Subclinical hypothyroidism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 1-12 years 2. Diagnosis of subclinical hypothyroidism by paediatrician 3. Understanding of Dutch language by parents.
Exclusion criteria
Exclusion criteria: 1. Clinical hypothyroidism (FT4 25) 5. Diabetes Mellitus type 1 6. Cow*s milk allergy. 7. Known or suspected disorder of intestinal absorption (e.g. celiac disease). 8. Disorders requiring a special diet. 9. Any relevant congenital abnormality, anatomical abnormality, chromosomal disorder or severe disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are (measured with venapunction at 0,3 and 6 months): - TSH-level (measurement with electro-chemiluminescence sandwich immunoassay on a COBAS 6000 (Roche Diagnostics)). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Anti-TPO (venapunction at 0 and 6 months) - Length and weight (at 0, 3 and 6 months) - Tiredness questionnaire, age-dependent for 2-4y, 5-7y, 8-12y and 13-18y (recorded by Pediatric QoL Multidimensional Fatigue Scale, Mapi Research Trust) - Lipid profile (which includes; Total cholesterol, HDL, LDL, chol:HDL ratio, triglycerides) (venapunction at 0, 3 and 6 months). Other study parameters: Parents will receive a questionnaire with various baseline characteristics (e.g. ethnicity, social environment, gestational age, birth weight) | — |
Countries
Netherlands